Evaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP

Prostatic Neoplasms Clinical Trial

Official title:

Evaluating the Effect of the Vacuum Constriction Device on Erectile Function and Penile Length Post Radical Retropubic Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177125
• Other study ID #: 0406M61241
• Secondary ID: 3358B
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: February 3, 2012
• Start date: January 2004
• Est. completion date: January 2004

Study information

• Verified date: February 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to perform a randomized prospective study to evaluate whether the vacuum erection device facilitates an earlier return of erectile function post radical prostatectomy. A secondary measure will be to evaluate if the vacuum erection device can help prevent penile shortening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing a radical prostatectomy for prostate cancer who are able to attain a partial or full erection preoperatively and are sexually active.

Exclusion Criteria:

• Patients on anticoagulation therapy and those with bleeding diatheses

• Insufficient manual dexterity of patient or spouse

• IIEF(International Index of Erectile Function) at baseline < 11, indicating severe erectile dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostatectomy
• Prostatic Neoplasms

Intervention

Device:
• ErectAid

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	VAMC Minneapolis	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Endocare, Inc., Manoj, Monga, M.D.

Country where clinical trial is conducted

United States,